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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies
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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"


WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            
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To sort by data column: 25 orders  
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Sort By Date 522 Order Date 522
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Study
Name
Date Original
Plan
Accepted
Study Status
PS120001 Acell, Inc. Acell matristem pelvic floor matrix General &
Plastic Surgery		 01/03/2012 POP AE and Effectiveness rates, registry 09/08/2013 Progress Inadequate
PS140001 Argo Medical Technologies, Inc Rewalk Physical Medicine 06/26/2014 ReWalk Registry 05/05/2016 Progress Inadequate
PS160001 Bayer Healthcare, LLC Essure system for permanent birth control Obstetrics/
Gynecology		 02/29/2016 Postmarket Surveillance Study 09/02/2016 Progress Adequate
PS110005 Biomet Inc. Porous titanium acetabular augments, m2a magnum 12/14 taper inserts and one-piece modular heads Orthopedic 05/06/2011 Metal Ion Levels 02/13/2012 Progress Adequate
PS110004 Biomet Microfixation Total temporomandibular joint replacement system Dental 02/04/2011 Explant 01/20/2012 Progress Adequate
PS120081 Boston Scientific Xenform soft tissue repair matrix General &
Plastic Surgery		 01/03/2012 POP AE and Effectiveness rates, registry 09/27/2013 Progress Adequate
PS120093 Boston Scientific Corporation Solyx Single Incision Sling System General &
Plastic Surgery		 01/03/2012 SUI AE and Effectiveness rates 01/31/2013 Progress Adequate
PS130044 Boston Scientific Corporation Pinnacle LITE Pelvic Floor Repair Kits - Uphold Lite Posterior and Uphold Obstetrics/
Gynecology		 07/03/2013 POP AE and Effectiveness rates, registry 09/10/2013 Progress Adequate
PS130039 Coloplast Corp Altis single incision sling system Obstetrics/
Gynecology		 03/13/2013 AE and effectiveness rates 12/06/2013 Progress Adequate
PS120106 Coloplast Corp. Restorelle polypropylene mesh Obstetrics/
Gynecology		 04/09/2012 POP AE and Effectiveness rates, registry 05/17/2013 Progress Adequate
PS110029 DJO Global Encore clp offset total hip system, metal/metal hip system,fmp metal/metal acetabular insert, revelation stem,djo surgical revision femoral i-lip system, metal backed acetabular component, Orthopedic 05/06/2011 Clinical Study 10/15/2012 Progress Adequate
Device Retrieval Study 10/15/2012 Progress Adequate
PS150002 Fujifilm Medical Systems USA, Inc. Fujifilm duodenoscopes Gastroenterology/
Urology		 10/05/2015 Human Factors Study 08/01/2017 Progress Adequate
Sampling and Culturing Study 12/21/2016 Noncompliant
PS130041 Halt Medical Inc. Acessa system Obstetrics/
Gynecology		 06/17/2013 Newly Enrolled 02/28/2014 Progress Adequate
PS110038 Johnson and Johnson Depuy pinnacle metal-on-metal acetabular cup liners Orthopedic 05/06/2011 Metal ion levels 09/28/2012 Progress Adequate
Explant Analysis 07/06/2012 Progress Adequate
PS110070 MicroPort Metal transcend articulation system Orthopedic 05/06/2011 Metal Ion Levels Microport 01/30/2017 Progress Adequate
Explant 03/21/2017 Study Pending
Metal Ion Levels Wright 11/01/2012 Revised/Replaced Study
PS100001 MicroVention, Inc. Microvention hydrocoil-soft-frame Neurology 04/15/2010 HydroSoft/HydroFrame Study 05/31/2012 Progress Adequate
PS110002 Nexus CMF Tmj fossa-eminence/condylar prosthesis system Dental 02/04/2011 Registry Database 08/23/2013 Revised/Replaced Study
TMJ Fossa-Eminence and Condylar Pros 02/04/2011 Revised/Replaced Study
TMJ Registry Study - Total Revised/Replaced Study
TMJM Registry Study - Partial Revised/Replaced Study
Prospective Postmarket Surveillance Study Plan 02/04/2011 Progress Inadequate
Explant Analysis Study Plan 02/04/2011 Progress Adequate
PS150003 Olympus Medical Systems Corporation (OMSC. Duodenoscopes Gastroenterology/
Urology		 10/05/2015 Human Factors Study 09/01/2017 Progress Inadequate
Sampling and Culturing Study 11/22/2016 Noncompliant
PS160003 Parker Hannifin Corporation Indego Physical Medicine 04/15/2016 Indego Postmarket Surveillance Study 10/07/2016 Progress Adequate
PS150004 Pentax Medical Duodenoscopes Gastroenterology/
Urology		 10/05/2015 Human Factors Study 08/10/2017 Progress Inadequate
Sampling and Culturing Study 12/08/2016 Noncompliant
PS150001 Preceptis Hummingbird tympanostomy tube system Ear Nose & Throat 04/23/2015 Post-market Surveillance Study (PSS) 04/23/2015 Progress Inadequate
PS120111 St. Jude Medical, Inc. Riata, quicksite, quickflex, durata Cardiovascular 08/16/2012 Lead Externalization and Abrasion 02/22/2013 Progress Adequate
PS120110 Stryker Neurovascular Wingspan stent system and gateway pta balloon catheter Neurology 08/08/2012 Rates of Stroke and Death 06/17/2013 Progress Inadequate
PS110003 TMJ Concepts Patient-fitted tmj reconstruction prosthesis system Dental 02/04/2011 Time to Revision and Explant Analysis 01/13/2012 Progress Inadequate
PS110093 Zimmer Zweymueller-sl hip prosthesis stem Orthopedic 05/06/2011 Cross-Sectional Study 12/07/2012 Progress Inadequate
Explant Analysis 12/07/2012 Progress Adequate


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-2252
Silver Spring, MD 20993-0002

Phone: (301) 796-6068
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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